BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1812587 · Received August 17, 2010

    Report

    Report Number
    3004209178-2010-06172
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 20, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S PUMP WAS EXPLANTED DUE TO INFECTION. IT WAS UNCLEAR WHAT MEDICATION WAS IN THE PUMP. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFO WAS REQUESTED BUT NOT PROVIDED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N247326005| PROGRAMMER: MODEL 8835, LOT# NPG016263N| IMPLANTED:| EXPLANTED: